Not recruiting

Title: Study of everolimus with hormone therapy in women with high-risk breast cancer (ER-positive, HER2-negative) who are disease-free after initial treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on women with breast cancer that is hormone receptor-positive (ER+) and HER2-negative, who have completed their initial treatment but have a high risk of the cancer returning. The study examines whether adding a medication called everolimus (Afinitor) to standard hormone therapy can help prevent the cancer from coming back.

The medication being tested, everolimus, is taken as tablets by mouth along with regular hormone therapy. Some participants will receive everolimus tablets while others will receive placebo tablets. The treatment continues for 2 years, during which time participants take their assigned medication in addition to their standard hormone therapy.

The main goal of this research is to determine if adding everolimus to standard hormone treatment helps keep patients cancer-free for a longer time. Throughout the study, doctors will monitor participants' health and track whether the cancer returns. The study will also look at how well patients tolerate the treatment combination and its effects on their overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be confirmed through medical examination and review of your breast cancer history
Laboratory tests will check your blood count, liver function, and kidney function to ensure they meet required levels
Your tumor status will be verified as hormone receptor positive and HER2 negative
Step 2
Treatment assignment
You will be randomly assigned to receive either Afinitor 5 mg tablets (everolimus) or placebo tablets
Both medications are taken by mouth
This assignment is double-blind, meaning neither you nor your doctor will know which treatment you receive
Step 3
Treatment period
The treatment duration is 2 years
You will continue your current hormone therapy (tamoxifen, letrozole, anastrozole, or exemestane)
You will take the study medication (Afinitor or placebo) in addition to your hormone therapy
Step 4
Monitoring
Regular check-ups will monitor your health status
Your doctor will assess any side effects using standard medical criteria
Quality of life assessments will be conducted using a questionnaire
Tests will be performed to check for any signs of cancer return
Step 5
Study completion
The study continues until March 2025
Your participation will help determine if adding everolimus to hormone therapy improves outcomes for breast cancer patients
The main measure of success is the time without return of cancer (disease-free survival)

Who can join the trial?

13 criteria

Must be a female aged 18 years or older
Must have adequate blood cell counts: - Normal levels of neutrophils (white blood cells that fight infection) - Normal levels of platelets (blood cells that help with clotting)
Must have normal liver function, shown by standard blood tests (AST, ALT, alkaline phosphatase, and bilirubin)
Must have normal kidney function, measured by blood creatinine levels
Must provide written informed consent to participate
Must have confirmed breast cancer that has been proven through tissue examination
Must have breast cancer that has not spread to other parts of the body
Must be at high risk for cancer returning
Must have breast cancer that is: - Hormone receptor positive (responds to hormones) - HER2 negative (does not have high levels of HER2 protein)
Must have had the primary tumor completely removed by surgery
Must either: - Be ready to start hormone therapy, or - Have been on hormone therapy for no more than 4 years
Must have no signs of cancer spread at the time of joining the study
Must be able to perform daily activities with little or no assistance (good performance status)

Who cannot join the trial?

13 criteria

Previous or current diagnosis of metastatic breast cancer (cancer that has spread to other parts of the body)
Male patients (study is only open to female participants)
Patients with HER2-positive or hormone receptor-negative breast cancer
Patients who are not currently disease-free after initial treatment
Patients who are not receiving standard hormone therapy
Patients with signs of cancer recurrence
Current participation in other clinical trials
History of serious allergic reactions to similar medications
Severe kidney or liver problems
Uncontrolled medical conditions that could interfere with the study
Inability to follow study procedures or attend scheduled visits
Pregnancy or breastfeeding
History of other cancers within the past 5 years (except treated non-melanoma skin cancer)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Everolimus
is a medication that works by helping to stop cancer cells from growing. It belongs to a group of drugs called mTOR inhibitors. In breast cancer treatment, it works alongside hormone therapy to help prevent the cancer from returning in patients who have hormone receptor-positive breast cancer.
Hormone therapy
(also called endocrine therapy) is a treatment that blocks or lowers the amount of hormones in the body to stop or slow down the growth of hormone-dependent breast cancer. This therapy is commonly used after surgery in women with hormone receptor-positive breast cancer to reduce the risk of cancer coming back.

What is already known about the treatment

Everolimus
A targeted therapy medication taken orally in tablet form that belongs to the class of drugs called mTOR inhibitors. It works by blocking a specific protein (mTOR) that promotes cancer cell growth and division, particularly effective in hormone receptor-positive breast cancer treatment. This medication is currently approved and widely used in clinical practice as part of combination therapy for various cancers, including breast cancer, where it's specifically used in combination with hormonal therapy to prevent cancer recurrence in high-risk patients. The drug's mechanism of action involves interrupting cellular signaling pathways that cancer cells use to grow and multiply, making it particularly valuable in treating hormone receptor-positive, HER2-negative breast cancer cases.
Hormone Therapy
A standard endocrine treatment administered either orally or via injection, depending on the specific medication used, that works by either lowering hormone levels or blocking hormone receptors in breast cancer cells. This established treatment approach is fundamental in managing hormone receptor-positive breast cancer, working by preventing estrogen from stimulating cancer cell growth. The therapy is widely supported by extensive clinical evidence and is considered a cornerstone in breast cancer treatment, particularly for preventing disease recurrence in patients with hormone receptor-positive breast cancer.

Investigated diseases

Breast Cancer (ER-positive, HER2-negative) - A type of breast cancer characterized by the presence of estrogen receptors (ER+) but lacking human epidermal growth factor receptor 2 (HER2-). This cancer begins when abnormal cells in the breast tissue start growing uncontrollably. The cancer cells in this type respond to the hormone estrogen, which can stimulate their growth. These cancer cells typically develop in the milk ducts or milk-producing glands of the breast. The disease can remain localized within the breast or spread to nearby lymph nodes. This particular subtype is one of the most common forms of breast cancer.